Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

Parkinson's Disease Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522379
• Other study ID #: SP0921
• Status: Completed
• Phase: Phase 3
• First received: August 28, 2007
• Last updated: October 17, 2014
• Start date: July 2007
• Est. completion date: July 2011

Study information

• Verified date: December 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Ministry of HealthPeru: Ministry of HealthChile: Ministry of HealthMexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.

Description:

To maintain treatment blind, two different active patch sizes were used (10 cm^2 & 20 cm^2). Placebo patches matched according to size and appearance. During the trial subjects applied up to three patches, active and placebo, to achieve their assigned daily dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• PD greater than 3 years

• Stable dose L-dopa but symptoms not adequately controlled and have "off" time

• Able and willing to complete diary on specific days

Exclusion Criteria:

• Previous use of rotigotine or Neupro

• Atypical Parkinson's syndrome

• Pallidotomy

• Thalamotomy

• Deep brain stimulation

• Fetal tissue transplant

• Dementia

• Psychosis

• Hallucinations

• Epilepsy

• Renal or hepatic dysfunction

• Clinically relevant cardiac dysfunction

• Symptomatic orthostatic hypotension

• Skin sensitivity to adhesives or unresolved contact dermatitis

• History of chronic alcohol or drug abuse

• Pregnant or of child-bearing potential

• Impulse control disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rotigotine
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
• Rotigotine
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks

Other:
• Placebo
Placebo transdermal patch applied daily

Drug:
• Rotigotine
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
• Rotigotine
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Chile,  India,  Mexico,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in the Absolute Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary	Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in Relative Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary	Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Absolute Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary	Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Relative Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary	Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary		From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period	The Unified Parkinson's Disease Rating Scale (UPDRS) Part II is a scale for the assessment of function in Parkinson's disease. UPDRS Part II measures Activities of Daily Living. It consists of 13 questions, each ranging from 0 to 4. The sum score of the UPDRS Part II ranges from 0 to 52. A higher score indicates greater disability. A negative change score indicates improvement.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period	The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change score indicates improvement.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present?	Item = Duration (question #32) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - What proportion of the waking day are dyskinesias present? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.; Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias?	Item = Disability (question #33) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How disabling are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.; Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias?	Item = Painful Dyskinesia (question #34) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How painful are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.; Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia	Item = Presence of Early Morning Dystonia (question #35) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates early morning dystonia.; Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Predictable?	Item = Are "off" periods predictable (question #36) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods are predictable.; Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Unpredictable?	Item = Are "off" periods unpredictable (question #37) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods are unpredictable.; Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do "Off" Periods Come on Suddenly?	Item = Do "off" periods come on suddenly, within a few seconds (question #38) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods come on suddenly, within a few seconds.; Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject "Off", on Average?	Item = What proportion of the waking day is the subject "off", on average (question #39) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 - 4 points (4 = maximum). A higher score indicates the subject is "off" a larger portion of the waking day.; Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting?	Item = Does the patient have anorexia, nausea, or vomiting (question #40) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has anorexia, nausea, or vomiting.; Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence?	Item = Does the patient have any sleep disturbances such as insomnia or hypersomnolence (question #41) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has sleep disturbances such as insomnia or hypersomnolence.; Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis?	Item = Does the patient have symptomatic orthostasis (question #42) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has symptomatic orthostasis.; Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No
Secondary	The Change in Number of "Off" Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary	Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.	From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].	No